Quifenadine

In response to the clinical treatment needs of leprosy, a chronic infectious disease, clofazimine, as a second-generation aminophenazine anti-leprosy drug, brings new treatment options for patients with drug-resistant leprosy with its unique mechanism of action. It mainly exerts a bacteriostatic effect by inhibiting the dihydrofolate reductase activity of Mycobacterium leprae and blocking the nucleic acid synthesis process of pathogenic bacteria. Meanwhile, it has an anti-inflammatory effect, which can significantly reduce the risk of leprosy reactions. Clinically, it is mainly used to treat various types of dapsone-resistant leprosy, and can also be combined with other anti-leprosy drugs for the combined chemotherapy of multibacillary leprosy. The applicable population includes patients who are resistant to first-line anti-leprosy drugs and cannot tolerate the adverse reactions of dapsone, so it is an important supplementary drug in the leprosy treatment system.

At present, the global market size of anti-leprosy drugs is approximately USD 320 million, among which second-line anti-leprosy drugs such as clofazimine account for about 18%, and the compound annual growth rate is maintained at around 4.2%. As leprosy is a neglected tropical disease, the number of manufacturers worldwide is small, and the market supply is concentrated in a few enterprises with special drug production qualifications. China is one of the major suppliers of clofazimine API in the world, with a production capacity accounting for more than 60% of the global total production capacity, and its products are mainly exported to Southeast Asia, Africa and other regions with high incidence of leprosy.

The original research enterprise of clofazimine is Novartis Pharma Stein AG, USA, and the original research brand name is Lamprene. Its core compound patent expired globally in 2004, and there is no core patent under research restricting it at present. The main dosage form approved for the original research is capsules with a specification of 50 mg per capsule. This dosage form has been included in the FDA Orange Book Reference Listed Drug Catalogue, and also included in China's *Catalogue of Reference Listed Drugs for Chemical Drugs (Third Batch)*. At present, 2 domestic enterprises have obtained CDE registration numbers for clofazimine API, all of which are in status A (activated). In addition, 1 enterprise's clofazimine capsules were approved for marketing in 2021, and passed the quality and efficacy consistency evaluation of generic drugs. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of clofazimine impurity reference standards, covering a total of 12 process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different stages such as API R&D, quality research, registration and declaration.